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Hepatitisweb study
Hepatitisweb study
Interferon alfa-2b +/- Ribavirin for 24 or 48 weeks
Phase 3
Treatment Naïve, Chronic HCV
McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.
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Hepatitisweb study
Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Outline
• Study- Randomized, double-blinded, placebo controlled, phase 3 trial- Conducted in 44 centers in United States
• Subjects- N = 912 with chronic hepatitis C - Treatment naïve; 72% genotype 1
• Regimens - Interferon alfa-2b + Placebo x 24 or 48 weeks - Interferon alfa-2b + Ribavirin (weight based) x 24 or 48 weeks
• Primary Endpoint- Undetectable serum HCV RNA 24 weeks after stopping treatment
Source: McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.
*Ribavirin weight based dosing: <75 kg = 1000 mg/day; >75 kg = 1200 mg/day
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Hepatitisweb study
Interferon + Ribavirin(n = 228)
Interferon(n = 225)
Interferon (n = 231)
48 720Week
Source: McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.
Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Design
Drug DosingInterferon alfa-2b 3 million U 3x/weekWeight-based Ribavirin (divided bid): 1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg
SVR24
Interferon + Ribavirin(n = 228)
SVR24
24
SVR24
SVR24
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Hepatitisweb study
Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Results
SVR 24, by Treatment Regimen
Source: McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.
Interferon _x000d_(24 weeks)
Interferon _x000d_(48 weeks)
Interferon + Ribavirin _x000d_(24 weeks)
Interferon + Ribavirin _x000d_(48 weeks)
0
10
20
30
40
50
6
13
31
38
Patie
nts
with
SVR
24
(%)
13/231 29/225 70/228 87/228
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Hepatitisweb studySource: McHutchison JG, et al. N Engl J Med. 1998;339:1485-92.
Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Conclusions
Conclusions: “In patients with chronic hepatitis C, initial therapy with interferon and ribavirin was more effective than treatment with interferon alone.”
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Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Onlinewww.hepatitisc.uw.edu
Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.